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INSPIRE: Innovative Strategies for Personalized Immunotherapies and Reservoir Eradication

Award Number: UM1AI191237
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/24/2025
PERIOD OF PERFORMANCE END DATE: 05/31/2030

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INSPIRE: Innovative Strategies for Personalized Immunotherapies and Reservoir Eradication - PROJECT SUMMARY/ABSTRACT Antiretroviral therapy (ART) is highly effective against HIV-1 and has saved millions of lives. However, ART is not curative, and people living with HIV (PWH) require life-long therapy because they harbor integrated replication-competent proviruses that quickly fuel rebound when ART is discontinued. This reservoir of infected cells represents the major barrier to long-term ART-free HIV-1 control, and interventions aimed at decreasing or eliminating them remains a priority. A growing body of evidence shows that the intact, rebound-competent HIV- 1 reservoirs evolve over time in response to ongoing immunologic pressure. Importantly, reservoir composition, integration landscapes and transcriptional activity are variable among PWH. These observations highlight the need for tools to carefully characterize bona fide reservoirs and identify key drivers of persistence to tailor approaches that are more likely to effectively perturb reservoirs, and prevent the return of viremia upon ART cessation. The object of the proposed program – “INSPIRE: Innovative Strategies for Personalized Immunotherapies and Reservoir Eradication” – is to tailor a combination of immunologic approaches that disrupt latency and enhance cellular and humoral responses to effectively control or eliminate rebound competent reservoirs in vivo. The program will leverage new methods our groups developed to generate engineered and authentic reservoir CD4+ T-cells clones and engineer B cells to produce broadly neutralizing anti-HIV-1 antibodies. We will use the newly available technologies to characterize reservoirs of PWH, to define the rules governing susceptibility of silent or transcriptionally active intact proviruses to latency reversal and cell-mediated killing, and perform proof of concept experiments to suppress SHIV-1 infection long-term in the absence of ART. These technologies will be applied to categorize ‘reservoir types’ and to select interventions most likely to eliminate reservoir clones in an individual or individuals with similar ‘reservoir types’. Our program is structured in three Research Focus Areas: (1) Apply and improve platforms to isolate authentic clones of CD4+ T-cells carrying latent HIV-1 proviruses and produce engineered reporter CD4+ T-cell clones representing varied responses to bNAb therapy and use these reagents to tailor therapeutic strategies, including the selection of new clinically viable latency reserving agents, (2) Assess elimination of reservoir clones by tailored cytotoxic T lymphocytes (CTL)- and natural killer (NK)-based approaches and link to in vivo impact of broadly neutralizing antibody (bNAb) treatment, and (3) Engineer long-lasting, high-level expression of bNAbs to control established simian-human immunodeficiency virus (SHIV) infections as proof of concept towards tailored HIV-1 control.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $2,915,052 )
2026	2026	WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY	575 LEXINGTON AVE FL 9	NEW YORK	NY	10022	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	5/28/2026	NON-COMPETING CONTINUATION	$2,915,052
														Subtotal = $2,915,052

Issue Date FY: 2025 ( Subtotal = $2,948,452 )
2025	2025	WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY	575 LEXINGTON AVE FL 9	NEW YORK	NY	10022	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	7/23/2025	NEW	$2,948,452
														Subtotal = $2,948,452

Grand Total All Awards = $5,863,504

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INSPIRE: Innovative Strategies for Personalized Immunotherapies and Reservoir Eradication

Award Number: UM1AI191237

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/24/2025

PERIOD OF PERFORMANCE END DATE: 05/31/2030

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